a schizophrenic. most likely went off his meds. another unfortunate, yet powerful, reason why long-acting injectable antipsychotic medications should be front line therapy in this country.
why would anyone want to be invested in the independent lab space. industry is imploding, growth anemic and will get worse, and free cash flow yield isn't any better than other large caps in healthcare.
that is not correct. PR typically comes just a few minutes before the data presentation. furthermore, company is under no obligation to present anything at all at a medical conference as this is just an interim update.
sounds like you're new to healthcare investing. you are way off base. every company puts out the PR just before the presentation. go back and look at GILD, BIIB, AMGN to name a few.
what a ridiculous company. more adjustments and non-gaap figures then any company I've ever seen. in reality, this is company has $670M in revenue and 4% operating margin and zero gaap eps growth. generated a paltry $30M in free cash this year.
i suggest you do some research before posting. the EF are right on the TCT presentation. seeking alpha article has the link. the improvement is better than any drug or device has ever shown ( 20% in many cases).
the data is on the TCT presentation. seekingalpha article has the link. 20% LVEF absolute improvement in early experience. no competitive treatment even comes close.
not sure what data you are looking but in one patient the LVEF was 45% and he also turned off his c pulse. another patient at 35% and reduced his usage by 1/2. st. luke's did an entire presentation on patients weaning themselves.
patient 2 was off c-pulse and EF essentially unchanged. how is that not recovered? patient 1 is now class I HF and patient 3 has reduced his usage of c-pulse by half. my point is you are looking at the wrong metric.
the trial end point is freedom from heart failure related hospitalization, lvad implantation, transplant or death. LVEF isn't even a secondary endpoint. the fact that patients are weaned or weaning themselves off c-pulse bodes very well for the trial success.
for the the fda and cardiologists, EF has never been accepted as anything more than a weak surrogate endpoint.
even impella's PROTECT II trial used the hard endpoint of heart attack, death, hospitalization and not ejection fraction, even though it is only used for temporary support. it will sell about $160M this year.
hard clinical outcomes are what matter which is why the fda required such endpoints in sunshine heart's trial.
even giving you the benefit of the doubt on the outsized importance EF, the trial is a comparison to current medical therapy where there is zero benefit on EF, more likely a rapid deterioration and should experience even worse outcomes. by your own criteria, c-pulse should have an easy time beating the current standards.
second, we already know the trial is open for five years. enrollment completes in 2016 with a 12 month endpoint? why is this news?
a better marker of mortality is....mortality. that's why these trials use hard endpoints and fda doesn't use LVEF. you're barking up the wrong tree here.
i was going to say that 35% or lower EF as a cut-off for inclusion into the US trial doesn't seem unreasonable to me.
as for the use of medications during the trial, I am almost 100% sure that enrollees continue receiving medication and medical therapy. the Counter-HF trial is set up like every other cardiac trial (e.g. thoratec, heartware, abiomed etc) where the device is added on top of the medical therapy.
stock is in a downward channel, like many biotech/high beta healthcare stocks (alny, pcyc, regn etc). nothing concerning at all. will breakout of channel shortly.
negative for cholesterol lowering drugs that don't show true health benefit, like improved mortality. insurance companies now have even less incentive to pay for these..
"Mark Schoenebaum, an analyst with ISI Group, said the new heart-protection guidelines "appear to raise the bar for cholesterol-lowering drugs" that are not statins. He said use of Amgen's PCSK9 inhibitor, called AMG 145, if it is approved, could be slowed until data from the drug's outcomes trial arrives in late 2017 or early 2018."
"I read the new guidelines as a negative for any drugs that aren't statins, including PCSK9 inhibitors," said Jon LeCroy, an analyst with MKM Partners."